Bob Steininger is senior vice president for chemistry manufacturing and control at Surface Oncology, Inc. He has worked for 34 years in pharmaceutical manufacturing following the start of his career in process design for coal conversion. In 2008, he was senior vice president for manufacturing at Acceleron Pharma.
During AIChE’s centennial year of 2008, AIChE interviewed Bob Steininger to learn his visions for the profession’s future. In today’s blog post, we contrast Steininger’s comments from 2008 with his perspectives today.
In 2008, Steininger wrote:
[Looking to the next 25 years], the pharmaceutical and medical industries must deal with the gradual aging of the population and the cost of medical treatment for individuals.
The most efficient way to provide medical attention is to treat early and treat prophylactically. Tools to determine the likelihood that an individual will develop a particular condition or that characterize an existing condition (e.g., breast cancer) already exist. I suspect such tests will be more ubiquitously used since I believe the benefit of knowledge that doing such tests brings — if the test is sufficiently specific and predictive — will warrant the cost. Making such tests easy, reproducible, and simple will be a challenge, particularly if ultimately one monitors a wide spectrum of variables simultaneously. Thus, creating the processes to make the instruments and the test kits (and often the test reagents) could and may benefit from cross-functionally trained engineers. In addition, such predictive health scans may be based on DNA or serum proteins.
In both cases, the magnitude of data will be great even for one individual, let alone multiple runs over time so that one can compare among populations.
Cyber and data analysis tools (similar to those used by my chemical engineer son now working on monitoring a few such biomarkers in cancer cells) will need to be developed to handle the scope and breadth of data, which could be mined to make drugs more specific for an individual.
If successful, existing drugs could be better targeted for specific individuals with known genetic profiles that are most responsive to those drugs.
However, the converse may also be feasible. Specific disease states may also require individualized drugs. To a certain extent, this is being attempted now. Individual patient tumors are being used as the source of cancer antigens to make antibodies or T cells, which are targeted to bind and destroy the antigen presenting tumor cell. Such individualized medicine for a limited number of patients with a specific set of disease characteristics (potential 10- to 100-fold less than an orphan drug, which is limited to treating no more than 100,000 people) is a unique challenge for a process engineer worried about drug economics.
Having started my career in alternative energy [in the 1980s], I also believe that chemical engineers will be essential to meeting the challenge of making the United States less reliant on external energy sources in the future. The fundamentals of heat and mass balance and a foundation in physical chemistry and thermodynamics make a chemical engineer particularly useful in most of the alternative energy sources as well as those activities involved in treating the waste from such activities, whether they be gaseous or solid. In addition, some exposure to the fundamentals of biotechnology as part of the training would make a chemical engineer an essential part of the team developing any process or managing a plant which is based on a biological process. However, given the greater propensity of potential electrochemically based systems, some additional education in this area may be helpful.
Here are Steininger’s perspectives in 2018:
Genes and gene information are becoming more important to biochemical engineers. The biotech industry has expanded the monitoring of gene expression, used to determine the probability of a new drug’s success. We are doing this regularly in the development of new drugs. In fact, the regulatory authorities expect submissions to include such data. As such, activity assays based not only on cell function but also on gene expression are becoming part of the release process. In addition, DNA analysis and DNA quantitation are now being used for release of product (gene therapy) and for monitoring the level of processes for impurities (virus, bacteria), helping to make production more cost-effective.
However, the character of biotherapeutic drugs, and how they are used in treatment of disease, is rapidly changing. Production processes that have been developed by chemical engineers will need to be modified. Now, more proteins are being used in combination with other protein drugs. As such, the need for less-expensive biologic-based drugs will become important as these combination drugs are approved.
Many companies are considering the use of continuous production processes to better control product properties and cost. The need to maintain a continuous process in the context of growing organisms, and to monitor, understand, and control the variables that yield consistent product in a manufacturing environment, will be a challenge to engineers; not a new challenge, but one which has been faced before in many industries outside of drug production.
In addition, the processes used to make new biopharmaceuticals are changing. New drugs enable cells within the body to make products that the patient lacks (e.g., gene therapy, modified bacteria as drugs). Cells from the body are also isolated, modified, and re-introduced to the patient to eliminate cancer (cell therapy). The processes to make these new drugs require steps for production and purification that are similar, but not identical, to those used previously.
Many of the assays used to monitor the process need to be developed. The product is often a live cell. In addition, the average target population is much smaller than the number of patients treated previously with the original biologic drugs. Often, the patient is only treated once.
This new area of biotechnology is becoming crowded and is rapidly expanding. As such, the biochemical engineer will need to focus his or her work on efficiency and speed of production, as well as accommodating the nature of these live or modified viruses used as drugs. In addition, the goal will be to rapidly determine what gene(s)/gene products need to modified for specific diseases, and then to rapidly make safe, sufficient drugs that can be used in focused clinical trials, with patients selected by their genome modifications/variants. The hope is that such selection might rapidly result in selecting drugs that can be approved more quickly.
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